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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/30/2013
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2013. The patient's wound was flushed and irrigated, and the lead was placed in a different location. Antibiotics were prescribed. A physician indicated that the patient was very slender and skinny: a tie-down was visible. The patient's parents did not notice anything in terms of patient manipulation or trauma. There had been no changes in the previous few months.

 
Event Description

On (b)(6) 2013, it was reported that, for some time, there was has been swelling at the neck incision site. The swelling is now red, and since a few days, the incision is open. The lead is visible. The generator and lead were to be explanted. Attempts for additional information have been unsuccessful.

 
Event Description

Reporter indicated per the mother the infection was first noted on (b)(6) 2013, but redness at the incision site had been present since early (b)(6) 2013. The patient went to the hospital emergency room on (b)(6) 2013. On (b)(6) 2013, it was previously felt there was an issue due to ¿a piece of the electrode being visible in the neck¿, and the ¿electrode¿ was placed ¿lower¿ by the surgeon. The infection was felt to be due to ¿chronic low grade infection on foreign material (stimulator). ¿ no device manipulation or trauma occurred. Wound cultures were done which identified (b)(6) bacteria. The vns generator and lead were explanted on (b)(6) 2013.

 
Manufacturer Narrative

Device manufacturing records were reviewed. : review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2976167
Report Number1644487-2013-00499
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2013
Device MODEL Number302-20
Device LOT Number2355
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/25/2013 Patient Sequence Number: 1
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